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Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252612
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
This study will treat resectable cutaneous squamous cell carcinoma patients with pramlintide for two weeks prior to surgical resection of their tumor. Pre-treatment and surgical resection specimens will then be analyzed for biological alterations.

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Drug: Pramlintide Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: Pramlintide 60 mcg twice daily
Participants will self inject Pramlintide 60 mcg twice daily for two weeks prior to surgical resection of tumor.
Drug: Pramlintide
SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.
Other Names:
  • Symlin
  • SymlinPen

Experimental: Cohort 2: Pramlintide 60 mcg three times daily
Participants will self inject Parmlintide 60 mcg three times daily for two weeks prior to surgical resection of tumor.
Drug: Pramlintide
SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.
Other Names:
  • Symlin
  • SymlinPen

Experimental: Cohort 3: Pramlintide 120 mcg three times daily
Participants will self inject Parmlintide 120 mcg three times daily for two weeks prior to surgical resection of tumor.
Drug: Pramlintide
SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.
Other Names:
  • Symlin
  • SymlinPen




Primary Outcome Measures :
  1. Participant Compliance [ Time Frame: at 14 days from on study date ]
    Patients who complete at least 75% of the injections and have not missed 2 consecutive days of treatment will be considered compliant.


Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: at 44 days from on study date ]
    Number of adverse events prior to surgery, during surgery and for 30 days after surgery that may be related to pramlintide injection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven cutaneous squamous cell carcinoma. Mixed histologies (basaloid, spindle, sarcomatoid, etc.) are allowed if the pathology review favors squamous cell carcinoma as the majority component. Cancers of unknown primary sites are allowed if the clinical history and the site are highly suggestive of a skin cancer primary
  • Tumor site must be amenable for surgical resection and accessible for pre-treatment biopsy
  • Tumor site must be measurable by caliper measurements or by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 imaging - lesions must be ≥1 cm
  • Eastern Cooperative Oncology Group (ECOG) ≤2 and be medically able to undergo surgical resection
  • Laboratory Requirements: Hemoglobin ≥ 8 g/dl, Platelet count ≥ 50,000/dl, Serum Creatinine ≤ 1.5 mg/dL OR Glomular Filtration Rate (GFR) ≥ 40, Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2.5x ULN; Total Bilirubin < 1.5x ULN (for patients with documented history of Gilbert's syndrome, total bilirubin level should be < 3.0 X ULN)
  • Ability to understand and willingness to sign a written informed consent document
  • Patients with child bearing potential must be willing to use barrier protection to prevent pregnancy while on study therapy and up to 30 days after the last dose of pramlintide
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Patients must be willing to comply with the protocol for the duration of the treatment including daily sub-cutaneous (SQ) injections, biopsies, scheduled visits and examinations, radiologic studies, and surgical resection

Exclusion Criteria:

  • Type I diabetes: Type II diabetics (DM2) on insulin are allowed, however, for those DM2 patients that are on short acting insulin, the insulin dose should be reduced 50% and need to have regular glucose monitoring (see section 6.2.1). Type II diabetics not on insulin will not be eligible.
  • Patients with known gastroparesis
  • Patients with known allergic reactions to pramlintide or its ingredients
  • Pregnant women and/or nursing patients will be excluded from this study because of unknown risks to fetus or nursing infants
  • Any serious or uncontrolled medical disorder that could interfere with the current study as deemed by the investigating physician
  • Participation in any other clinical study using an investigational agent within 21 days of starting treatment on this protocol
  • No prior chemotherapy, radiation, or other tumor directed therapy within 21 days prior of starting treatment on this protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252612


Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Neha Pathak    813-745-5170    Neha.Pathak@Moffitt.org   
Principal Investigator: Nikhil Khushalani, MD         
Sub-Investigator: Andrew Brohl, MD         
Sub-Investigator: Zeynep Eroglu, MD         
Sub-Investigator: Elsa Flores, PhD         
Sub-Investigator: Joseph Markowitz, MD, PhD         
Sub-Investigator: Amod Sarnaik, MD         
Sub-Investigator: Vernon Sondak, MD         
Sub-Investigator: Ahmad Tarhini, MD, PhD         
Sub-Investigator: Kenneth Tsai, MD, PhD         
Sub-Investigator: Jonathan Zager, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Nikhil Khushalani, MD Moffitt Cancer Center
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04252612    
Other Study ID Numbers: MCC-19708
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pramlintide
Hypoglycemic Agents
Physiological Effects of Drugs